Office of the Institutional Review Board

Guidance

Note: Posted Guidance documents on this website do not represent an all inclusive list. Please call the Office of the IRB at 210-567-8250 with any questions concerning current guidance.

Instructions:

Always return to this webpage to ensure you are using the most current Guidance.

Document Instructions/Information

Advertising - Guidelines for Advertising for Research Subjects

Related Policy: Identification and Recruitment of Participants

Assurance Letter

A letter containing the UTHSCSA FWA number, numbers of the IRBs listed under this FWA and a list of affiliated institutions covered by the IRB under general IRB Authorization Agreements.
Community Participatory Research Guidance on community participatory research

Consenting Process - Guidance on Observation of the Consenting Process

Related Policy: Informed Consent

Related SOP: Obtaining Informed Consent

Department of Defense Research DoD Research Policy and Procedure

Existing Specimens

Guidelines for IRB Applications Involving the Use of Existing Specimens

Gender Differences

FDA Guidance on Study of Gender Differences in the Clinical Evaluation of Drugs
LAR - Guidance related to legally effective informed consent under HHS, FDA, VA regulations and Texas state law “Legally Authorized Representatives Under Federal and Texas Law”

Data and Safety Monitoring Plan

IRB Guidance on DSMP
IRB of Record Guidance on Serving as IRB of Record
Medical Directive Information about Advance Medical Directive from Prepare for your Care website
Informed Consent Obtaining Informed Consent SOP
Planned Emergency - Guidance on Planned Emergency Research, Exception from Informed Consent, and Waiver of Applicability of Informed Consent Related Policy: Planned Emergency Research

Power of Attorney

Information about Medical Power of Attorney, Statutory Durable Power of Attorney from the Texas Health and Human Services website

Pregnancy Exposure Registry

FDA Guidance for Industry: Establishing Pregnancy Exposure Registries
Recruitment - Guidance on UT Medicine Patient Recruitment Related Policy: Identification and Recruitment of Participants

Waivers and Alterations Guidance

Related Policy: Informed Consent